Cited by 2,693Meta-analysis and systematic reviewsClinical practice guidelines implementationDelphi Technique in Research

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GRADE guidelines 6. Rating the quality of evidence—imprecision

Guyatt, Gordon H., Oxman, Andrew D., Kunz, Regina, Brozek, Jan, Alonso-Coello, Pablo, Rind, David, Devereaux, P.J., Montori, Victor M., Freyschuss, Bo, Vist, Gunn, Jaeschke, Roman, Williams, John W., Murad, Mohammad Hassan, Sinclair, David, Falck-Ytter, Yngve, Meerpohl, Joerg, Whittington, Craig, Thorlund, Kristian, Andrews, Jeff, Schünemann, Holger J.·2011·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2011.01.012

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Abstract

GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required if clinical action would differ if the upper versus the lower boundary of the CI represented the truth. An exception to this rule occurs when an effect is large, and consideration of CIs alone suggests a robust effect, but the total sample size is not large and the number of events is small. Under these circumstances, one should consider rating down for imprecision. To inform this decision, one can calculate the number of patients required for an adequately powered individual trial (termed the "optimal information size" [OIS]). For continuous variables, we suggest a similar process, initially considering the upper and lower limits of the CI, and subsequently calculating an OIS. Systematic reviews require a somewhat different approach. If the 95% CI excludes a relative risk (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (we suggest an RR of under 0.75 or over 1.25 as a rough guide) rating down for imprecision may be appropriate even if OIS criteria are met.

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Authors: Guyatt, G. H., Oxman, A. D., Kunz, R., Brozek, J., Alonso-Coello, P., Rind, D., Devereaux, P. J., Montori, V. M., Freyschuss, B., Vist, G., Jaeschke, R., Williams, J. W., Murad, M. H., Sinclair, D., Falck-Ytter, Y., Meerpohl, J., Whittington, C., Thorlund, K., Andrews, J., & Schünemann, H. J.
Affiliations: McMaster University (CA)
Nasjonalt Kunnskapssenter for Helsetjenesten (NO)
University Hospital of Basel (CH)
Harvard University (US)
Karolinska University Hospital (SE)
Duke Medical Center (US)
Mayo Clinic (US)
Liverpool School of Tropical Medicine (GB)
Case Western Reserve University (US)
University Medical Center Freiburg (DE)
University College London (GB)
Vanderbilt University (US)
Corresponding author: Guyatt, Gordon H.
ORCID: Guyatt, Gordon H.
Oxman, Andrew D.
Kunz, Regina
Devereaux, P.J.
Freyschuss, Bo
Vist, Gunn
Jaeschke, Roman
Williams, John W.
Murad, Mohammad Hassan
Falck-Ytter, Yngve
Meerpohl, Joerg
Whittington, Craig
Thorlund, Kristian
Schünemann, Holger J.
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2011-12
Volume: 64
Issue: 12
Pages: 1283-1293
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2011.01.012
OpenAlex: W2090132603
Cited by: 2,693
References: 31
Citations by year: 2026: 189 · 2025: 194 · 2024: 255 · 2023: 217 · 2022: 266 · 2021: 260 · 2020: 224 · 2019: 165 · 2018: 186 · 2017: 179 · 2016: 172 · 2015: 162 · 2014: 96 · 2013: 69 · 2012: 48
FWCI: 73.46
Type: journal article
Language: en
Update notices: erratum (2021-09-01)
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords: GRADE, quality of evidence, imprecision, confidence intervals, sample size, number of events, relative risk, continuous outcomes, systematic reviews, clinical guidelines
MeSH terms: Humans, Risk, Meta-Analysis as Topic, Confidence Intervals, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Sample Size, Evidence-Based Medicine

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